Health Communication, Risk Behavior, Smoking, Smoking Behaviors, Smoking, Tobacco
Conditions
Brief summary
The investigators will conduct a message-exposure experiment with nationally representative samples of smokers, dual-users (cigarettes and e-cigarettes), and young adult non-smokers (aged 18-29). Experimental messages will address the reduction of nicotine in cigarettes. Participants will also complete a follow-up survey after 2 weeks, measuring their recall of the messages and behaviors since message exposure.
Detailed description
A national probability-based sample will be recruited to include 900 current exclusive smokers, 450 dual users, and 450 young adult (18-29) non-smokers, evenly split between men and women. The study will be conducted using a self-administered, online questionnaire via proprietary, web-assisted interviewing software. Participants are randomized to one of four conditions: * reduced nicotine messages * modified risk messages * a combination of reduced nicotine message and modified risk message * control messages with no cigarette-related content Participants will take part in two sessions: in session 1 (estimated at about 15 min) participants will see the messages and report immediate outcomes including risk perceptions. In session 2, which will take place 2 weeks after session 1, participants will complete a brief 5-minute survey measuring their recall of the messages and behaviors since message exposure.
Interventions
BEHAVIORALReduced nicotine message exposure
Participants will be shown two messages about harms of reduced nicotine cigarettes. The two messages will be drawn from a pool of five messages. The messages will communicate that reduced nicotine cigarettes will still have the rest of the harmful chemicals and cause diseases as the regular cigarettes, but they would make it easier to quit.
BEHAVIORALModified risk message exposure
Participants will be shown two messages about electronic cigarettes as an alternative to regular cigarettes. The two messages will be drawn from a pool of five messages. The messages will communicate that electronic cigarettes are less likely than regular cigarettes to cause severe diseases such as lung cancer.
BEHAVIORALCombined message exposure (reduced nicotine + modified risk)
Participants will be shown two messages, one from the reduced nicotine message set and one modified risk message set.
BEHAVIORALControl message exposure
Participants will be shown two messages about drinking bottled water. These will be selected from a pool of five message. The messages display specific water products and describe hydration as a healthy activity.
Sponsors
Georgia State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Being 18 years old or older: * Belonging to one of three groups of participants; 900 current exclusive smokers, 450 dual users (cigarettes and e-cigarettes), and 450 young adult (18-29) non-smokers, evenly split between men and women. * Enrolled in existing nationally representative panel where recruitment is based
Exclusion criteria
\- None.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Health Risk of VLNCs (Absolute) | Immediately after exposure | Measured with a single item, assesses participant's perception of own risk of overall harm to health under conditions of smoking reduced nicotine cigarettes every day. Response options range from 1 (Not at all likely) to 5 (Extremely likely), with higher scores representing a better outcome. An additional option, Don't know, is also provided. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intention to Switch From Cigarettes to Electronic Nicotine Products | Immediately after exposure | A single item measuring intention (during the next 6 months) to switch completely from cigarettes to electronic nicotine products. Response options are from 1 (not at all likely) to 7 (extremely likely), with higher scores representing a better outcome. An additional option, Don't know, is also provided. |
| Perceived Addictiveness of VLNCs | Immediately after exposure | A single item measuring participants' perception of likelihood of developing addiction to reduced nicotine cigarettes under conditions of smoking them every day. Response options are from 1 (Not at all likely) to 5 (Extremely likely), with higher scores representing a worse outcome. An additional option, Don't know, is also provided. |
| VLNC Comparative Risk Perceptions | Immediately after exposure | A single item measuring perceptions of comparative risk of smoking reduced nicotine cigarettes vs regular cigarettes. Response options are from 1 (Much less harmful) to 5 (Much more harmful), with higher scores representing a better outcome. An additional option, Don't know, is also provided. |
| Interest in Trying Reduced Nicotine Cigarettes | Immediately after exposure | A single item measuring how interested a participant is in trying reduced nicotine cigarettes. Response options are from 1 (not at all) to 7 (extremely), with higher scores representing a worse outcome. An additional option, Don't know, is also provided. |
| Perceived Message Effectiveness | Immediately after exposure | A three-item scale measuring to what extent participants think the messages they saw discourage them from wanting to smoke, make smoking seem unpleasant, and make them concerned about health risks of smoking. Response options: from 1 (Disagree) to 4 (Neither Disagree nor Agree) to 7 (Strongly Agree). Higher scores represent a better outcome. The final perceived message effectiveness score is the mean of the response to the three items. |
| Perceived Health Risk of VLNCs (Absolute) at Post-test | Two weeks after exposure | Measured with a single item, assesses participant's perception of own risk of overall harm to health under conditions of smoking reduced nicotine cigarettes every day. Response options range from 1 (Not at all likely) to 5 (Extremely likely), with higher scores representing a better outcome. An additional option, Don't know, is also provided. |
| Smoking Behavior | Two weeks after exposure | Single item measuring the average number of cigarettes smoked per day in the past two weeks. |
| VLNC Policy Support | Immediately after exposure | A single item measuring support for the policy to reduce nicotine by 95% in all cigarettes. Response options are from 1 (Strongly Oppose) to 5 (Strongly Support), with higher scores representing a better outcome. An additional option, Don't know, is also provided. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited through a panel. Participants were pre-identified based on internal data on age and smoking status: adults who exclusively smoked cigarettes, adults who dual used cigarettes and e-cigarettes, and young adults (aged 18-29) who never smoked.
Pre-assignment details
The panel sample (probability sample) included 971 adults who smoked exclusively, 240 adults who dual used cigarettes and e-cigarettes, and 458 young adults (18-29 years old) who never smoked. To augment the sample of adults who dual used, additional participants were recruited from the opt-in, non-probability sample (n=232) bringing the total sample size to 1901.
Participants by arm
| Arm | Count |
|---|---|
| Reduced Nicotine Messages Participants will receive messages with information about reduced nicotine cigarettes.
Reduced nicotine message exposure: Participants will be shown two messages about harms of reduced nicotine cigarettes. The two messages will be drawn from a pool of five messages. The messages will communicate that reduced nicotine cigarettes will still have the rest of the harmful chemicals and cause diseases as the regular cigarettes, but they would make it easier to quit. | 468 |
| Modified Risk Messages Participants will receive messages with information about e-cigarettes.
Modified risk message exposure: Participants will be shown two messages about electronic cigarettes as an alternative to regular cigarettes. The two messages will be drawn from a pool of five messages. The messages will communicate that electronic cigarettes are less likely than regular cigarettes to cause severe diseases such as lung cancer. | 484 |
| Combined Message -- Reduced Nicotine + Modified Risk Exposure Participants will receive messages about reduced nicotine cigarettes and about e-cigarettes.
Combined message exposure (reduced nicotine + modified risk): Participants will be shown two messages, one from the reduced nicotine message set and one modified risk message set. | 476 |
| Control Participants will receive messages about bottled water which should have no impact on the outcomes of interest.
Control message exposure: Participants will be shown two messages about drinking bottled water. These will be selected from a pool of five message. The messages display specific water products and describe hydration as a healthy activity. | 473 |
| Total | 1,901 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 89 | 101 | 102 | 99 |
Baseline characteristics
| Characteristic | Reduced Nicotine Messages | Modified Risk Messages | Combined Message -- Reduced Nicotine + Modified Risk Exposure | Control | Total |
|---|---|---|---|---|---|
| Age, Customized 18-29 years | 128 Participants | 141 Participants | 134 Participants | 147 Participants | 550 Participants |
| Age, Customized 30-44 years | 105 Participants | 110 Participants | 114 Participants | 112 Participants | 441 Participants |
| Age, Customized 45-59 years | 119 Participants | 112 Participants | 106 Participants | 108 Participants | 445 Participants |
| Age, Customized 60+ | 116 Participants | 121 Participants | 122 Participants | 106 Participants | 465 Participants |
| Race/Ethnicity, Customized Black, non-Hispanic | 49 Participants | 63 Participants | 52 Participants | 61 Participants | 225 Participants |
| Race/Ethnicity, Customized Hispanic | 55 Participants | 63 Participants | 46 Participants | 54 Participants | 218 Participants |
| Race/Ethnicity, Customized Other, non-Hispanic | 20 Participants | 19 Participants | 11 Participants | 21 Participants | 71 Participants |
| Race/Ethnicity, Customized Two Races or more, non-Hispanic | 16 Participants | 25 Participants | 19 Participants | 16 Participants | 76 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 328 Participants | 314 Participants | 348 Participants | 321 Participants | 1311 Participants |
| Region of Enrollment United States | 468 Participants | 484 Participants | 476 Participants | 473 Participants | 1901 Participants |
| Sex: Female, Male Female | 255 Participants | 262 Participants | 259 Participants | 240 Participants | 1016 Participants |
| Sex: Female, Male Male | 213 Participants | 222 Participants | 217 Participants | 233 Participants | 885 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Perceived Health Risk of VLNCs (Absolute)
Measured with a single item, assesses participant's perception of own risk of overall harm to health under conditions of smoking reduced nicotine cigarettes every day. Response options range from 1 (Not at all likely) to 5 (Extremely likely), with higher scores representing a better outcome. An additional option, Don't know, is also provided.
Time frame: Immediately after exposure
Population: The number of participants analyzed included all participants in each condition who responded to the outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Reduced Nicotine Messages | Perceived Health Risk of VLNCs (Absolute) | 4.09 score on a scale |
| Modified Risk Messages | Perceived Health Risk of VLNCs (Absolute) | 3.81 score on a scale |
| Combined Message -- Reduced Nicotine + Modified Risk Exposure | Perceived Health Risk of VLNCs (Absolute) | 4.03 score on a scale |
| Control | Perceived Health Risk of VLNCs (Absolute) | 3.87 score on a scale |
Secondary
Intention to Switch From Cigarettes to Electronic Nicotine Products
A single item measuring intention (during the next 6 months) to switch completely from cigarettes to electronic nicotine products. Response options are from 1 (not at all likely) to 7 (extremely likely), with higher scores representing a better outcome. An additional option, Don't know, is also provided.
Time frame: Immediately after exposure
Population: The number of participants analyzed included participants who 1) are adults who smoked exclusively and adults who dual used and 2) responded to the outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Reduced Nicotine Messages | Intention to Switch From Cigarettes to Electronic Nicotine Products | 3.15 score on a scale |
| Modified Risk Messages | Intention to Switch From Cigarettes to Electronic Nicotine Products | 2.97 score on a scale |
| Combined Message -- Reduced Nicotine + Modified Risk Exposure | Intention to Switch From Cigarettes to Electronic Nicotine Products | 2.91 score on a scale |
| Control | Intention to Switch From Cigarettes to Electronic Nicotine Products | 2.86 score on a scale |
Secondary
Interest in Trying Reduced Nicotine Cigarettes
A single item measuring how interested a participant is in trying reduced nicotine cigarettes. Response options are from 1 (not at all) to 7 (extremely), with higher scores representing a worse outcome. An additional option, Don't know, is also provided.
Time frame: Immediately after exposure
Population: The number of participants analyzed included all participants in each condition who responded to the outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Reduced Nicotine Messages | Interest in Trying Reduced Nicotine Cigarettes | 3.09 score on a scale |
| Modified Risk Messages | Interest in Trying Reduced Nicotine Cigarettes | 2.95 score on a scale |
| Combined Message -- Reduced Nicotine + Modified Risk Exposure | Interest in Trying Reduced Nicotine Cigarettes | 3.08 score on a scale |
| Control | Interest in Trying Reduced Nicotine Cigarettes | 3.15 score on a scale |
Secondary
Perceived Addictiveness of VLNCs
A single item measuring participants' perception of likelihood of developing addiction to reduced nicotine cigarettes under conditions of smoking them every day. Response options are from 1 (Not at all likely) to 5 (Extremely likely), with higher scores representing a worse outcome. An additional option, Don't know, is also provided.
Time frame: Immediately after exposure
Population: The number of participants analyzed included all participants in each condition who responded to the outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Reduced Nicotine Messages | Perceived Addictiveness of VLNCs | 3.68 score on a scale |
| Modified Risk Messages | Perceived Addictiveness of VLNCs | 3.74 score on a scale |
| Combined Message -- Reduced Nicotine + Modified Risk Exposure | Perceived Addictiveness of VLNCs | 3.65 score on a scale |
| Control | Perceived Addictiveness of VLNCs | 3.71 score on a scale |
Secondary
Perceived Health Risk of VLNCs (Absolute) at Post-test
Measured with a single item, assesses participant's perception of own risk of overall harm to health under conditions of smoking reduced nicotine cigarettes every day. Response options range from 1 (Not at all likely) to 5 (Extremely likely), with higher scores representing a better outcome. An additional option, Don't know, is also provided.
Time frame: Two weeks after exposure
Population: The analysis population included participants in each condition that responded to the outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Reduced Nicotine Messages | Perceived Health Risk of VLNCs (Absolute) at Post-test | 3.68 score on a scale |
| Modified Risk Messages | Perceived Health Risk of VLNCs (Absolute) at Post-test | 3.62 score on a scale |
| Combined Message -- Reduced Nicotine + Modified Risk Exposure | Perceived Health Risk of VLNCs (Absolute) at Post-test | 3.68 score on a scale |
| Control | Perceived Health Risk of VLNCs (Absolute) at Post-test | 3.62 score on a scale |
Secondary
Perceived Message Effectiveness
A three-item scale measuring to what extent participants think the messages they saw discourage them from wanting to smoke, make smoking seem unpleasant, and make them concerned about health risks of smoking. Response options: from 1 (Disagree) to 4 (Neither Disagree nor Agree) to 7 (Strongly Agree). Higher scores represent a better outcome. The final perceived message effectiveness score is the mean of the response to the three items.
Time frame: Immediately after exposure
Population: The number of participants analyzed included all participants who responded to all three outcome measures.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Reduced Nicotine Messages | Perceived Message Effectiveness | 4.55 score on a scale |
| Modified Risk Messages | Perceived Message Effectiveness | 3.98 score on a scale |
| Combined Message -- Reduced Nicotine + Modified Risk Exposure | Perceived Message Effectiveness | 4.32 score on a scale |
| Control | Perceived Message Effectiveness | 2.33 score on a scale |
Secondary
Smoking Behavior
Single item measuring the average number of cigarettes smoked per day in the past two weeks.
Time frame: Two weeks after exposure
Population: The number of participants analyzed included participants who 1) are adults who smoked exclusively and adults who dual used and 2) responded to the outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Reduced Nicotine Messages | Smoking Behavior | 11.64 number of cigarettes/day |
| Modified Risk Messages | Smoking Behavior | 11.97 number of cigarettes/day |
| Combined Message -- Reduced Nicotine + Modified Risk Exposure | Smoking Behavior | 12.78 number of cigarettes/day |
| Control | Smoking Behavior | 11.97 number of cigarettes/day |
Secondary
VLNC Comparative Risk Perceptions
A single item measuring perceptions of comparative risk of smoking reduced nicotine cigarettes vs regular cigarettes. Response options are from 1 (Much less harmful) to 5 (Much more harmful), with higher scores representing a better outcome. An additional option, Don't know, is also provided.
Time frame: Immediately after exposure
Population: The number of participants analyzed included all participants in each condition who responded to the outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Reduced Nicotine Messages | VLNC Comparative Risk Perceptions | 2.97 score on a scale |
| Modified Risk Messages | VLNC Comparative Risk Perceptions | 2.81 score on a scale |
| Combined Message -- Reduced Nicotine + Modified Risk Exposure | VLNC Comparative Risk Perceptions | 2.89 score on a scale |
| Control | VLNC Comparative Risk Perceptions | 2.78 score on a scale |
Secondary
VLNC Policy Support
A single item measuring support for the policy to reduce nicotine by 95% in all cigarettes. Response options are from 1 (Strongly Oppose) to 5 (Strongly Support), with higher scores representing a better outcome. An additional option, Don't know, is also provided.
Time frame: Immediately after exposure
Population: The number of participants analyzed included all participants in each condition who responded to the outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Reduced Nicotine Messages | VLNC Policy Support | 3.20 score on a scale |
| Modified Risk Messages | VLNC Policy Support | 3.08 score on a scale |
| Combined Message -- Reduced Nicotine + Modified Risk Exposure | VLNC Policy Support | 3.21 score on a scale |
| Control | VLNC Policy Support | 3.14 score on a scale |